Emergency Peripartum Hysterectomy: A Prospective Study in Iran

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01285258
First received: January 26, 2011
Last updated: NA
Last verified: March 2004
History: No changes posted
  Purpose

The purpose of this study is to determine the effects of peripartum hysterectomy for maternal hemorrhage.


Condition Intervention Phase
Postpartum Hemorrhage
Procedure: hysterectomy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Peripartum Hysterectomy for Maternal Hemorrhage

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • death rate [ Time Frame: at 2 minutes after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • urological complication [ Time Frame: at 2 minutes after operation ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: March 2004
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
peripartum
patients whom underwent peripartum hysterectomy
Procedure: hysterectomy
excluding the uterus with saving ovaries

Detailed Description:

Emergency peripartum hysterectomy is a life-saving surgical procedure which performed to control massive hemorrhage. This study was conducted to determine the factors leading to and maternal mortality and morbidity rates among the women whose underwent peripartum hysterectomy with the focus on referral or non-referral patient status.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who have nonresponse hemorrhage after delivery

Exclusion Criteria:

  • Women who delivered before 24 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285258

Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: hamidreza shemshaki, MD MD,research comittee
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01285258     History of Changes
Other Study ID Numbers: ASD-1213-13
Study First Received: January 26, 2011
Last Updated: January 26, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
Peripartum
hysterectomy
placenta accreta
mortality

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage

ClinicalTrials.gov processed this record on July 28, 2014